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Separation of somatropin charge variants by multiple-injection CZE with Polybrene/chondroitin sulfate A double-coated capillaries
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Analytical Pharmaceutical Chemistry.
2013 (English)In: Journal of Separation Science, ISSN 1615-9306, E-ISSN 1615-9314, Vol. 36, no 16, 2686-2690 p.Article in journal (Refereed) Published
Abstract [en]

The performance of dynamic double-coated fused-silica capillaries with Polybrene and chondroitin sulfate A has been compared with uncoated fused-silica capillaries for the determination of recombinant human growth factor (somatropin) charge variants. The separations were carried out under the same electrophoretic conditions as described in the European Pharmacopoeia, i.e. at pH 6.0 and 30 degrees C. The coating significantly reduced the interactions between the proteins and the surface of the fused-silica capillary. The first five separations performed in a new bare fused-silica capillary were discarded because of very poor separation performance as a result of protein-surface interactions. There was an approximate twofold increase in the interday migration time precision (%RSD 6.5%) in the double-coated capillaries. The method was successfully transferred to a multiple CZE mode where two samples were analyzed in a single electrophoretic run. The average purity of somatropin certified reference standard was 98.0% (%RSD 0.3%) determined by using uncoated and coated capillaries.

Place, publisher, year, edition, pages
2013. Vol. 36, no 16, 2686-2690 p.
Keyword [en]
CZE, Double-coated capillaries, European Pharmacopoeia, Somatropin charge variants, Somatropin CRS
National Category
Natural Sciences Medical and Health Sciences
URN: urn:nbn:se:uu:diva-206993DOI: 10.1002/jssc.201300327ISI: 000322994600017OAI: oai:DiVA.org:uu-206993DiVA: diva2:646415
Available from: 2013-09-09 Created: 2013-09-09 Last updated: 2013-09-09Bibliographically approved

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Amini, Ahmad
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Analytical Pharmaceutical Chemistry
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